Pre-exposure Prophylaxis Adherence Intervention for MSM (PrEPare)

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Sexual Risk Compensation [ Time Frame: At each of the 9 study visits spread over up to six months. ]

This is primarily a feasiblity RCT. Sexual risk compensation is defined as a potential change in sexual risk taking behaviors (unprotected anal sex). This is measured daily with text message assessments for sexual risk as well as at each study visit with self-report measure(s).

Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.

evidence of high risk for HIV acquisition defined by having unprotected anal sex (insertive or receptive) with an HIV-positive male partner OR at least a total of three episodes of unprotected anal sex with at least two partners in the last three months

participants who are not able to consent due to psychiatric or cognitive concerns

those who have already been prescribed PrEP

having a history of or current medical conditions that would preclude taking the study drug (e.g., previously diagnosed active and serious infections, acute or chronic hepatitis B, history of pathological bone fractures not related to trauma)

receiving ongoing therapy with ART, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion, or other investigational agents

receiving or possibly receiving antiretroviral drugs for an anti-HIV vaccine in a clinical trial

active alcohol or drug use that would interfere with study participation

having other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects